ISO 14065 Documentation Toolkit

The contents of the ISO 14065 Documentation Toolkit include more than 80 files in 6 directories, as listed below:

Quality Manual (11 chapters): A Quality manual for a validation/ verification body. It covers the management system as per the requirements of requirement against each clause.

1. Exhibits (7 exhibits): The 7 exhibits include, as per ISO 14065, like skill requirements, etc., which are given.
2. Standard Operating Procedures (3 SOPs): It covers standard operating procedures.
3. Blank Forms and Templates (48 forms): A set of 48 templates and standard forms to demonstrate the implementation of a Quality Management System.

All the documents provided are editable, and the users can easily modify the name of the company, its logo, and other details required for their company.

1. Quality Manual (11 Chapters and 48 Pages):

A Comprehensive Manual, Based on the Structure of ISO 14065. The solution comes with a detailed manual consisting of 11 chapters and 48 pages. The manual covers each and every requirement and gives reference to procedures related to specific requirements of the standard.

2. Procedures (18 procedures):

The mandatory procedures as per ISO 14065 are provided in this ISO 14065 Documentation Toolkit, which covers all the details like purpose, scope, responsibility, how the procedure is followed, as well as the list of exhibits, reference documents, and formats. The list of sample procedures provided in the kit is as follows.

List of Procedures included in ISO 14065 Documentation Toolkit

1. Planning of validation/verification Procedure for ISO 14065
2. Execution of validation/verification activities: Procedure for ISO 14065
3. Receive, evaluate and resolve complaints: Procedure for ISO 14065
4. Management Review Procedure for ISO 14065
5. Identification and management of nonconformities and corrective action Procedure for ISO 14065
6. Document and Data Control Procedure for ISO 14065
7. Effective control of validation/ verification activities delivered by entities under its operational control procedure for ISO 14065
8. Procurement of external products and services: Procedure for ISO 14065
9. Review of the request for validation/verification Procedure for ISO 14065
10. Review and Reporting Procedure for ISO 14065
11. Receive, evaluate, and make decisions on appeals: Procedure for ISO 14065
12. Use of marks by the client: Procedure for ISO 14065
13. Internal Audit Procedure for ISO 14065
14. Risk Assessment Procedure for ISO 14065
15. Control of Records Procedure for ISO 14065
16. Impartiality Management Procedure for ISO 14065
17. Personnel and Training Procedure for ISO 14065
18. Management of competence of personnel: Procedure for ISO 14065

3. Exhibits (7 exhibits)

A sample of exhibits, as per ISO 14065, is provided. The list of sample exhibits provided in the kit is as follows.

List of Exhibits of ISO 14065 Documentation Toolkit

1. Principles and scope of accreditation
2. Documentation structure and codification system
3. Impartiality policy
4. Confidentiality policy
5. Operational control plan
6. Competence requirements
7. Calibration periodicity

4. Standard Operating Procedures (3 SOPs):

The SOPs given in this kit are sample copies of standard operating procedures as per ISO 17029. The list of sample standard operating procedures provided is as below.

List of Standard Operating Procedures of ISO 14065 Documentation Toolkit

1. SOP for Protection and backup of electronics records
2. SOP for Site Safety
3. SOP for Evaluator qualification

5. Blank formats for all the departments (48 sample formats)

This directory of ISO 14065 Documentation toolkit includes sample blank forms that are required to maintain records as well as establish control and create a system in the organization. The organization is free to change it to suit its own requirements. The blank formats can be used as templates. A total of 48 blank formats are provided as per the list given below.

List of blank formats included in ISO 14065 Documentation Toolkit

1. Complaint register
2. Quality objective monitoring report
3. Improvement/ Minutes of meeting
4. Circular
5. Minutes of Meeting
6. Audit plan/schedule
7. Internal Audit Non—Conformity Report
8. Clausewise audit report — Management requirements
9. Clausewise audit report — Technical requirements
10. Non—conformity work report
11. Corrective Action Report
12. Risk assessment and opportunity sheet
13. Masterlist and Distribution list of Documents
14. Change Note
15. Periodic document review report
16. Masterlist of Records
17. Inspection Report
18. Sub-contractors/ External service providers’ agreement
19. Validation / Verification request
20. Planning register
21. Client feedback
22. Validation / Verification agreement
23. Validation/verification plan
24. Validation/verification execution report
25. Calibration status of equipment
26. Equipment History Card
27. Validation/verification review and decision report
28. Validation/verification statement
29. Appeal report
30. Appeal registers
31. Complaint report
32. Impartiality check report
33. Control report
34. Training Calendar
35. Training Report
36. Induction Training Report
37. Job Description and Specification
38. Skill Matrix
39. Training Effectiveness Check Report
40. Interview report
41. Employee competence report
42. Competence assessment report
43. Purchase Order
44. Indent (Purchase requisition)
45. Supplier registration form
46. Approved External Providers List (Approved Vendor List)
47. Supplier Evaluation Report
48. Impartiality and confidentiality agreement